Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section and Postoperative Pain.

Cesarean Section Clinical Trial

Official title:

Efficacy of a Single-shot Wound Infiltration With Bupivacaine/Adrenalin During Cesarean Section in Reducing Postoperative Pain. A Randomized Prospective Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395912
• Other study ID #: 0151-17-EMC
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2022
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thus study evaluates the advantage of infiltration of the surgical wound by local anesthetics in cesarean section on post operative pain relief. In the study group before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration. Our hypothesis is that subcutaneous infiltration of the surgical wound by BUPIVACAINE + ADRENALIN at the end of cesarean section will reduce the intensity of post operative pain.

Description:

Cesarean section is one of the most common procedures in the world. There is an advantage in preventing pain after cesarean section, as opposed to treating pain that has already started. The infiltration of surgical wounds by local anesthetics is accepted as an effective method for preventing pain after various operations. In this study women who are admitted for a cesarean section will be randomly allocated into 2 groups. In the study group after the closure of the fascia above the rectus muscles, and before closing the skin, both sides of the incision (top and bottom) will be infiltrated by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin. In the control group, the skin will be closed without infiltration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• cesarean section with regional anesthesia
• singleton
• pfannenstiel incision

Exclusion Criteria:

• cesarean section with general anesthesia
• maternal liver or kidney disease
• allergy to Bupivacaine
• allergy to Adrenalin
• intrauterine fetal death
• major fetal malformations

Related Conditions & MeSH terms

• Cesarean Section
• Pain, Postoperative

Intervention

Drug:
• Intervention
After closing the fascia above the rectus muscles, and before closing the skin, the subcutaneous layer will be infiltrated on both sides of the incision (top and bottom) by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin.

Locations

Country	Name	City	State
Israel	HaEmek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (20)

Adesope O, Ituk U, Habib AS. Local anaesthetic wound infiltration for postcaesarean section analgesia: A systematic review and meta-analysis. Eur J Anaesthesiol. 2016 Oct;33(10):731-42. doi: 10.1097/EJA.0000000000000462. Review. — View Citation

Bensghir M, Elwali A, Miller C, Azendour H, Drissi M, Bakkali H, Belyamani L, Atmani M, Drissi Kamili N. [Effects of skin infiltration with ropivacaine 0,75% on postoperative pain after caesarean section]. Gynecol Obstet Fertil. 2008 May;36(5):516-20. doi — View Citation

Corsini T, Cuvillon P, Forgeot A, Chapelle C, Seffert P, Chauleur C. [Single-dose intraincisional levobupivacaine infiltration in caesarean postoperative analgesia: a placebo-controlled double-blind randomized trial]. Ann Fr Anesth Reanim. 2013 Jan;32(1): — View Citation

Ducarme G, Sillou S, Wernet A, Davitian C, Poujade O, Ceccaldi PF, Bougeois B, Luton D. [Single-shot ropivacaine wound infiltration during cesarean section for postoperative pain relief]. Gynecol Obstet Fertil. 2012 Jan;40(1):10-3. doi: 10.1016/j.gyobfe.2 — View Citation

Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24. — View Citation

Fredman B, Shapiro A, Zohar E, Feldman E, Shorer S, Rawal N, Jedeikin R. The analgesic efficacy of patient-controlled ropivacaine instillation after Cesarean delivery. Anesth Analg. 2000 Dec;91(6):1436-40. — View Citation

Givens VA, Lipscomb GH, Meyer NL. A randomized trial of postoperative wound irrigation with local anesthetic for pain after cesarean delivery. Am J Obstet Gynecol. 2002 Jun;186(6):1188-91. — View Citation

Jolly C, Jathières F, Keïta H, Jaouen E, Guyot B, Torre A. Cesarean analgesia using levobupivacaine continuous wound infiltration: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:125-30. doi: 10.1016/j.ejogrb.2015.08.023. Epub 2015 Aug — View Citation

Karlström A, Engström-Olofsson R, Norbergh KG, Sjöling M, Hildingsson I. Postoperative pain after cesarean birth affects breastfeeding and infant care. J Obstet Gynecol Neonatal Nurs. 2007 Sep-Oct;36(5):430-40. — View Citation

Lavand'homme PM, Roelants F, Waterloos H, De Kock MF. Postoperative analgesic effects of continuous wound infiltration with diclofenac after elective cesarean delivery. Anesthesiology. 2007 Jun;106(6):1220-5. — View Citation

Li X, Zhou M, Shi X, Yang H, Li Y, Li J, Yang M, Yuan H. Local anaesthetic wound infiltration used for caesarean section pain relief: a meta-analysis. Int J Clin Exp Med. 2015 Jun 15;8(6):10213-24. eCollection 2015. Review. — View Citation

Mecklem DW, Humphrey MD, Hicks RW. Efficacy of bupivacaine delivered by wound catheter for post-Caesarean section analgesia. Aust N Z J Obstet Gynaecol. 1995 Nov;35(4):416-21. — View Citation

Metaxotos NG, Asplund O, Hayes M. The efficacy of bupivacaine with adrenaline in reducing pain and bleeding associated with breast reduction: a prospective trial. Br J Plast Surg. 1999 Jun;52(4):290-3. — View Citation

Parascandola SA, Ibañez J, Keir G, Anderson J, Plankey M, Flynn D, Cody C, De Marchi L, Margolis M, Blair Marshall M. Liposomal bupivacaine versus bupivacaine/epinephrine after video-assisted thoracoscopic wedge resection†. Interact Cardiovasc Thorac Surg — View Citation

Pavy T, Gambling D, Kliffer P, Munro A, Merrick PM, Douglas J. Effect of preoperative skin infiltration with 0.5% bupivacaine on postoperative pain following cesarean section under spinal anesthesia. Int J Obstet Anesth. 1994 Oct;3(4):199-202. — View Citation

Sekhavat L, Behdad S. Preoperative analgesia with local lidocaine for cesarean delivery pain relief. J Matern Fetal Neonatal Med. 2011 Jul;24(7):891-3. doi: 10.3109/14767058.2010.537410. Epub 2011 Jan 10. — View Citation

Trotter TN, Hayes-Gregson P, Robinson S, Cole L, Coley S, Fell D. Wound infiltration of local anaesthetic after lower segment caesarean section. Anaesthesia. 1991 May;46(5):404-7. — View Citation

Tuncer S, Aysolmaz G, Reisli R, Erol A, Yalçin N, Yosunkaya A. [The effects of the administration of subfacial levobupivacaine infusion with the ON-Q pain pump system on postoperative analgesia and tramadol consumption in cesarean operations]. Agri. 2010 — View Citation

Yefet E, Taha H, Salim R, Hasanein J, Carmeli Y, Schwartz N, Nachum Z. Fixed time interval compared with on-demand oral analgesia protocols for post-caesarean pain: a randomised controlled trial. BJOG. 2017 Jun;124(7):1063-1070. doi: 10.1111/1471-0528.14546. Epub 2017 Feb 25. — View Citation

Zohar E, Shapiro A, Eidinov A, Fishman A, Fredman B. Postcesarean analgesia: the efficacy of bupivacaine wound instillation with and without supplemental diclofenac. J Clin Anesth. 2006 Sep;18(6):415-21. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported pain intensity upon receipt of a woman after cesarean section to the maternity department.	Visual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain.	up to 24 hours
Secondary	Length of the cesarean section	Time from first incision to the end of incision closure	up to 24 hours
Secondary	Time from surgery to mobility	Time from the end of surgery to mobility	up to 48 hours
Secondary	Time from surgery to breastfeeding	Time from the end of surgery to breastfeeding	up to 4 days
Secondary	Need for opioids	Type and dosage of opioids needed	up to 4 days
Secondary	Surgical site hematoma	Post operative surgical site hematoma	4 days
Secondary	surgical site infection	Post operative surgical site infection	up to 42 days
Secondary	questionnaire	Post operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction.	up to 4 days
Secondary	Length of stay from surgery to discharge	Length of stay from surgery to discharge	up to 4 days